ARTS-II Trial

1. ARTS-II Trial Arterial Revascularization Therapies Part II: a non-randomized comparison of contemporary PCI and coronary artery bypass grafting (CABG) in patients with multi-vessel coronary artery lesions Presented at The American College of Cardiology 2005

2. ARTS-II Trial 607 patients with multivessel coronary lesions 26.2% diabetic 54% 3 vessel disease 13.9% type C lesions Historical Controls from ARTS I: 1202 patients with multivessel coronary lesions 18.2% diabetic 28% 3 vessel disease 7.5% type C lesions Bare Metal Stent 2.8 stents per patient Avg total length: 48 mm n = 600 Sirolimus-eluting stent 3.7 stents per patient Avg total length: 73 mm n = 607 CABG n = 602 • Endpoints: • Primary – Major adverse cardiac and cerebrovascular events (MACCE), including death, cerebrovascular event, myocardial infarction, and revascularization, at 1 year for the comparison of CABG treated patients in the ARTS I trial with sirolimus-eluting stent patients in the ARTS II trial • Secondary – MACCE at 30 days, 6 months, 3 and 5 years. – Total cost at 30 days – Cost, cost effectiveness, quality of life at six mo, and 1, 3, and 5 years ACC 2005

3. ARTS II: Event free survival At one year, there was no difference in event-free survival between the ARTS II SES group and the ARTS I CABG group. However, the ARTS II group showed significantly higher rates of survival free from cardiac death, MI, and reintervention than the ARTS I bare metal stent group. The groups were not significantly different in the primary endpoint of survival free from MACCE. p = <0.001 p = 0.003 p = 0.46 ACC 2005

4. ARTS II: MACCE at one year Overall MACCE at 1 year • At 1 year, there was no difference in the incidence of MACCE between the ARTS II SES group and the ARTS I CABG group. • The ARTS I bare metal stent group was associated with a significantly higher rate of 1 year MACCE compared to the other groups ACC 2005 TCT 2004

5. ARTS II: components of MACCE At one year, there was no difference in any components of MACCE, including death, cerebrovascular events (CVE), MI, or revascularization with CABG or PCI between the ARTS II SES group and ARTS I CABG patients. The ARTS I bare metal stent group was associated with a significantly higher rate of revascularization with PCI compared to the ARTS II SES group. p=NS p=NS p=NS p=NS % ACC 2005

6. ARTS II: Summary • Among patients with multivessel coronary lesions, patients treated with sirolimus-eluting stents had significantly lower rates of MACCE compared with a historical registry of similar patients treated with bare metal stents and rates of MACCE statistically equivalent to patients from the same registry treated with CABG. • The majority of the difference in MACCE between the ARTS II and ARTS I BMS groups was driven by the increased need for repeat revascularization in the bare metal stent group. The ARTS II group had equal rates of revascularization to the ARTS I CABG group, despite having increased length and complexity of lesions. • While this historical registry comparison is promising and statistical measures were used to adjust for co-founding variables, a randomized trial is needed to adequately determine the superiority of one therapy over another. ACC 2005